title: Transvenous extraction of implantable cardioverter-defibrillator leads under advisory--a comparison of Riata, Sprint Fidelis, and non-recalled implantable cardioverter-defibrillator leads.
abstract: BACKGROUND
  Comparative safety and efficacy associated with transvenous lead extraction (TLE) of recalled and non-recalled implantable cardioverter-defibrillator (ICD) leads has not been well characterized.
  
  
  OBJECTIVE
  To compare the indications, techniques, and procedural outcomes of recalled vs non-recalled ICD lead extraction procedures.
  
  
  METHODS
  TLE procedures performed at our institution from June 2002 to June 2012 in which Riata, Sprint Fidelis, or non-recalled ICD leads were extracted were included in the analysis.
  
  
  RESULTS
  ICD lead extraction procedures were performed in 1079 patients, including 430 patients with recalled leads (121 Riata, 308 Sprint Fidelis, and 1 Riata and Sprint Fidelis) and 649 patients with non-recalled ICD leads. A total of 2056 chronic endovascular leads were extracted, of which 1215 (59.1%) were ICD leads. Overall, there was 96.8% complete procedural success, 99.1% clinical success, and 0.9% failure, with 3.9% minor complications and 1.5% major complications. Procedural outcomes for Riata and Sprint Fidelis TLE procedures were no different. Lead implant duration was significantly less in recalled than in non-recalled ICD lead TLE procedures. Complete procedural success was higher in recalled (424 of 430 [98.6%]) than in non-recalled (621 of 649 [95.7%]; P = .007) ICD lead TLE procedures. Minor complications were lower in recalled (10 of 430 [2.3%]) than in non-recalled (32 of 649 [5.0%]; P = .030) ICD lead TLE procedures. Rates of clinical success, failure, and major complications were no different in the recalled and non-recalled ICD lead TLE procedures.
  
  
  CONCLUSIONS
  In our experience, recalled ICD leads were extracted with safety and efficacy comparable to that of non-recalled ICD leads.
authors.affiliation: Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio.
authors.forename: Michael P
authors.initials: MP
authors.lastname: Brunner
authors.forename: Edmond M
authors.initials: EM
authors.lastname: Cronin
authors.forename: Jessen
authors.initials: J
authors.lastname: Jacob
authors.forename: Valeria E
authors.initials: VE
authors.lastname: Duarte
authors.forename: Khaldoun G
authors.initials: KG
authors.lastname: Tarakji
authors.forename: David O
authors.initials: DO
authors.lastname: Martin
authors.forename: Thomas
authors.initials: T
authors.lastname: Callahan
authors.forename: P Peter
authors.initials: PP
authors.lastname: Borek
authors.forename: Daniel J
authors.initials: DJ
authors.lastname: Cantillon
authors.forename: Mark J
authors.initials: MJ
authors.lastname: Niebauer
authors.forename: Walid I
authors.initials: WI
authors.lastname: Saliba
authors.forename: Mohamed
authors.initials: M
authors.lastname: Kanj
authors.forename: Oussama
authors.initials: O
authors.lastname: Wazni
authors.forename: Bryan
authors.initials: B
authors.lastname: Baranowski
authors.forename: Bruce L
authors.initials: BL
authors.lastname: Wilkoff
mesh_terms: D000368:Aged; D006328:Cardiac Catheterization; D017147:Defibrillators, Implantable; D020878:Device Removal; D004867:Equipment Design; D004868:Equipment Failure; D005260:Female; D006801:Humans; D008297:Male; D057052:Medical Device Recalls; D008875:Middle Aged; D018579:Patient Selection; D012189:Retrospective Studies; D013610:Tachycardia / Q000628:therapy*; D016896:Treatment Outcome
keywords: Advisory; EC; Extraction; FDA; Food and Drug Administration; HRS; Heart Rhythm Society; ICD; Implantable cardioverter-defibrillator; Lead; SVC; TLE; externalized conductor; implantable cardioverter-defibrillator; superior vena cava; transvenous lead extraction